News
Company statement
Tue, 10 Mar 2026 09:30:00 -0400
Tue, 10 Mar 2026 09:30:00 -0400
Novo Nordisk acknowledges receipt of Warning Letter and welcomes further dialogue with the US FDA
- Warning Letter relates to a Post-marketing Adverse Drug Experience (PADE) inspection conducted at the Plainsboro, NJ site in early 2025
- Company has and will continue to take measures to address Agency’s observations
- Patient safety is a top priority for Novo Nordisk, and we view FDA inspections seriously as well as opportunities to continuously improve our operations across the organization.
PLAINSBORO, N.J., March 10, 2026 – Following a Post-marketing Adverse Drug Experience (PADE) inspection conducted at the Plainsboro, NJ site in early 2025, Novo Nordisk received a Form FDA 483 of inspectional observations on February 7, 2025, and has been working diligently to address those observations ever since. On March 5, 2026, Novo Nordisk received a Warning Letter from the US Food and Drug Administration (FDA) related to the 2025 PADE inspection, to which Novo Nordisk is responding.
Since the inspection in early 2025, Novo Nordisk has been working to resolve the observations in the Form FDA 483 through its corrective and preventative action plan, and has kept the FDA informed on its progress, including through an initial response and seven updates. In the Warning Letter, the FDA acknowledges the significant measures Novo Nordisk has taken over the past year meant to ensure full compliance with PADE reporting requirements. The Warning Letter largely seeks additional details on these measures to confirm current and future regulatory compliance; it does not make any conclusions about the quality or safety of our medicines.
“Novo Nordisk takes PADE reporting requirements seriously and we plan to address the requests in the Warning Letter expeditiously and holistically,” shared Anna Windle, Head of Clinical Development, Medical and Regulatory Affairs, Novo Nordisk US. “We are confident that we will resolve the matters outlined in Warning Letter to the FDA’s full satisfaction.”
FDA inspections of pharmaceutical manufacturers are standard practice and are meant to ensure compliance with applicable regulations. If a patient experiences a potential side effect from a Novo Nordisk product, or if a healthcare provider becomes aware of a potential side effect from a Novo Nordisk product, they should report it at our Safety Reporting (novonordisk-us.com).
The Company does not expect this event to impact production or our guidance set forth in the Full Year Results reported out on February 4, 2026.
Commonly Asked Questions
Why has there been a long time between the inspection and the warning letter publication?
While we cannot speak for the communication actions of the FDA, what we can share is that since receipt of Form FDA 483 on February 7, 2025, the company has been working diligently to address the observations, as FDA indicates in the Warning Letter. The company initially responded to the Form FDA 483 within the Agency’s deadline, on March 3, 2025, and has shared seven updates since then with the Agency.
This is not the only regulatory communication Novo Nordisk has received from the FDA of late. Why is that?
We work in a highly regulated space, and we take each communication with the FDA very seriously.
Recent “Untitled Letters” for Ozempic® and Wegovy® were in response to each of the current advertising campaigns, and those responses, which are not related to this specific Warning Letter, are being managed.
Warning Letters recently received include this one, related to a PADE inspection at the Plainsboro, NJ site, and a second one related to a Good Manufacturing Practice (cGMP) inspection at the Bloomington, IN site in late 2025. We have full confidence that we will be able to holistically and promptly address the matters outlined in each of the Warning Letters.
What type of measures and corrective actions are you implementing in connection with the matters outlined in this Warning Letter? What are the progress points that you have been sharing with the FDA since early 2025?
As the FDA acknowledges in the Warning Letter, Novo Nordisk has undertaken many improvement efforts and has regularly communicated to FDA about them. The company initially responded to the Form FDA 483 within the Agency’s deadline, on March 3, 2025, and has shared seven updates with the Agency since then. Over the past year, Novo Nordisk has undertaken a broad, multi‑pronged effort to address the FDA PADE inspection—closing potential gaps while building durable and scalable pharmacovigilance capability. We are confident that we will be able to respond to the requests in the Warning Letter to the Agency’s full satisfaction.
About Novo Nordisk
Novo Nordisk is a leading global health care company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people across more than 10 manufacturing, R&D and corporate locations in eight states plus Washington, D.C. For more information, visit novonordisk-us.com, Facebook, Instagram, and X.
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